FDA Inspection 882847 — The Original Bradford Soap Works, Inc.
The FDA completed an inspection of The Original Bradford Soap Works, Inc. on Jun 11, 2014 in West Warwick, RI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 11, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- West Warwick, RI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3592 | 21 CFR 211.110(c) | In-process materials characteristics testing |